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Quality of Life of Patients With Colorectal Neoplasm and Cost-Effectiveness Analysis of Colorectal Cancer Screening

13 maj 2016 uppdaterad av: Professor Cindy L.K. Lam, The University of Hong Kong

A Study on Health-related Quality of Life of Patients With Colorectal Neoplasm and Cost-Effectiveness Analysis of Colorectal Cancer Screening in Hong Kong

Introduction: Colorectal cancer (CRC) is the second most common cancer among Chinese in Hong Kong and the second leading cause of cancer death in this population. Several screening strategies has been associated with improved survival and may affect patients' health-related quality of life (HRQOL). HRQOL impact should be used to adjust for survival in terms of quality adjusted life years (QALY) in the evaluation of cost-effectiveness of any intervention including screening.

Objectives: to determine the HRQOL and health preference of patients with different stages of colorectal neoplasm, and to determine the most cost-effective CRC screening strategy for increasing QALYs.

Design and Subjects: A longitudinal survey to collect data on HRQOL associated with colorectal neoplasm for Markov modeling on cost-effectiveness of CRC screening. A stratified sample of 420 patients with colorectal polyps and different stages of CRC will be recruited from colorectal clinics of Queen Mary Hospital for health preference and HRQOL assessment. The HRQOL over time will be measured at baseline, 6 and 12 months later. Health preference data will be integrated with cost and effectiveness data obtained from the literature to determine the cost-effectiveness of currently recommended CRC screening strategies by Markov modeling.

Main outcome measures: The primary outcome measure is the SF-6D health preference value and QALYs. Secondary outcomes are the SF-12v2 and FACT-C scores. The outcomes will be compared between patients with different stages of colorectal neoplasm. Markov modeling study will estimate the expected QALYs gained and incremental cost-effectiveness ratio for each CRC screening strategy.

Results: The study will provide information on HRQOL of patients with colorectal neoplasm to guide health services. The Markov Model will identify the most cost-effective CRC screening strategy for Hong Kong Chinese, which can inform policy makers and the public for the prevention of CRC of the population.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

The aims are to determine the HRQOL and health preference (utility) of different stages of colorectal neoplasm in order to evaluate the cost-effectiveness of different CRC screening strategies for the Chinese population in Hong Kong.

The specific objectives are:

  1. To determine the HRQOL preference values of patients in different stage of colorectal neoplasm in order to estimate the quality of life adjustment applicable to each stage of colorectal neoplasm.
  2. To evaluate the HRQOL of patients with colorectal neoplasm in order to find out their concerns and needs.
  3. To find out whether HRQOL preference of people with colorectal neoplasm changes with time.
  4. To determine the expected life years gained from the reduction in the incidence and mortality rates of CRC for each CRC screening strategy base on literature review.
  5. To determine the QALY gained from each CRC strategy by combining the preference value with life years gained.
  6. To identify the most cost-effective CRC screening strategy and to determine the incremental cost per additional QALY gained compared to no screening, by Markov modelling.

The study hypotheses are:

  1. Patients with colorectal neoplasm including those with polyps have lower HRQOL than the general population.
  2. There is a gradient reduction in HRQOL preference among patients with different stages colorectal neoplasm from polyp to metastatic cancer.
  3. HRQOL preference of patients with colorectal neoplasm is stable if there is no change in the disease stage.
  4. Annual I-FOBT is the most cost-effective CRC screening strategy for the Chinese population in Hong Kong.

Studietyp

Observationell

Inskrivning (Faktisk)

587

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Hong Kong
      • Hong Kong Island, Hong Kong
        • Department of Clinical Oncology, Faculty of Medicine, The University of Hong Kong
      • Hong Kong Island, Hong Kong
        • Department of Medicine, Queen Mary Hospital
      • Hong Kong Island, Hong Kong
        • Department of Surgery, Faculty of Medicine, The University of Hong Kong

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

All Chinese patients of 18 years old or above with a histology of confirmed colorectal polyp or cancer for at least six months were recruited from specialist outpatient medical and surgical colorectal clinics of Queen Mary hospital in Hong Kong.

Beskrivning

Inclusion Criteria:

  • Age 18 years or above
  • Have life expectancy of at least 6 months
  • Have confirmed diagnosis of any of the following colorectal neoplasm classified by the screening surveillance guideline and UICC/AJCC (TNM) staging system
  • Have given consent to take part in the study

Exclusion Criteria:

  • Inability to understand or communicate in Cantonese or Chinese
  • Significant cognitive impairment judged by the doctor to be unable to answer the questionnaire
  • Too ill to carry out an interview
  • Refuse to give consent

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Low-risk Colorectal Polyps
≤2 adenomas or 3-4 adenomas all of which are <1cm
High-risk Colorectal Polyps
≥5 adenomas or ≥3 adenomas at least one of which is ≥1cm
Stage I CRC
at least six months since diagnosis of Stage I CRC
Stage II CRC
at least six months since diagnosis of Stage II CRC
Stage III CRC
at least six months since diagnosis of Stage III CRC
Stage IV CRC
at least six months since diagnosis of Stage IV CRC

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
SF-6D Preference-based Value
Tidsram: Twelve months
HRQOL preference value measured by The Chinese (HK) SF-6D Health Survey was calculated by the HK population specific algorithm. It ranges from 0 (death) to 1 (perfect health).
Twelve months
Quality-adjusted life years for each screening strategy
Tidsram: Baseline
The effectiveness of CRC screening is quantified by Quality-adjusted life years, which was calculated as the product of average duration of each health state (including no illness) and the SF-6D preference value for that particular health state.
Baseline
Direct Health Care Costs for each CRC screening strategy
Tidsram: Baseline
The direct health care costs of different CRC screening strategies and treatments of different stages of CRC were estimated using the costs published by the Government Gazette.
Baseline

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
HRQOL by SF-12v2 and FACT-C
Tidsram: Twelve months
HRQOL measured by the SF-12v2 and FACT-C was evaluated to identify the major problems of life of CRC patients.
Twelve months
Health Service Utilizations
Tidsram: Baseline
Health service utilizations of patients with colorectal neoplasm were assessed to investigate their associations with HRQOL.
Baseline
Factors Associated with HRQOL
Tidsram: Baseline
Factors including type of treatments that may affect HRQOL of patients with CRC were explored.
Baseline

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The University of Hong Kong

Samarbetspartners

Food and Health Bureau, Hong Kong
Queen Mary Hospital, Hong Kong

Utredare

  • Huvudutredare: Cindy L.K. Lam, MD, Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2009

Primärt slutförande (Faktisk)

1 juli 2010

Avslutad studie (Faktisk)

1 juni 2012

Studieregistreringsdatum

Först inskickad

28 augusti 2013

Först inskickad som uppfyllde QC-kriterierna

14 januari 2014

Första postat (Uppskatta)

16 januari 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

16 maj 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 maj 2016

Senast verifierad

1 maj 2016

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • HKCTR-973

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